1. Field of the Invention
The present invention relates to the field of pharmaceutical compositions and their use to relieve the spasms associated with pain. It describes pharmaceutical compositions comprising an antispasmodic agent alone or in combination with analgesic agents such as a non-steroidal anti-inflammatory drug (NSAID) and/or pharmaceutically acceptable agents/excipients to relieve the spasms associated with pain.
The present invention provides a method for relieving spasms associated with pain wherein the pharmaceutical compositions comprising an antispasmodic agents are selected from a group consisting of a diol (with the total of 2 hydroxyl groups) or a triol (with a total of 3 hydroxyl groups) compound with carbon chain length of 4 to 8 and/or in combination with the analgesic agents, including NSAID agents, such as diclofenac, piroxicam, nimesulide, ketoprofen, ibuprofen, methyl salicylate; or steroidal agents, such as various anti-inflammatory corticosteroids, prednisone, etc.
2. Description of the Related Art
The majority of joint and muscle pain is associated with some kind of muscular spasms. Muscular spasm is defined by sudden involuntary contraction of a muscle or a group of muscles. These muscular spasms are associated with some kind of inflammation. Many times, the muscular inflammation is treated by oral non-steroidal agents (NSAIDs). However, utilizing oral dosage forms to treat localized join or muscle pain has a significant disadvantage of exposing the whole body to the drug. Topical application of anti-inflammatory agents offers the possibility of achieving local therapeutic benefit while reducing or eliminating the risk of systemic exposure and effects. As a result, diclofenac, piroxicam, nimesulide, ketoprofen, and hydrocortisone gel/cream/lotion/ointment have gained in popularity. While all of the anti-inflammatory compounds reduce the inflammation, they do little to reduce the muscle spasm.
U.S. Pat. No. 6,277,892 discloses an invention which relates to pharmaceutical compositions for topical application comprising a safe and effective amount of a pharmaceutical active, and from about 0.1% to about 10.0% of a high molecular weight cationic polymer. These compositions provide enhanced penetration of the pharmaceutical active. These compositions can also contain one or more additional humectants/moisturizers, many of which may also be useful as actives wherein the preferred humectants/moisturizers for use in the compositions of the present invention are the C3-C6 diols and triols. Especially preferred is the triol, glycerin.
EP 2340043 A1 discloses an invention which relates to a composition for improved transdermal drug delivery comprising a drug, a combination of at least two penetration enhancing agents, wherein at least one of the penetration enhancing agents is selected from the group consisting of esters of saturated or unsaturated fatty acids and lower alcohols, and iso-form alcohols; wherein at least one of the penetration enhancing agents is selected from the group consisting of aliphatic diols and triols; and wherein the components are present in a non-aqueous solvent system.
U.S. Pat. No. 8,236,348 discloses a dosage form wherein the dosage form is made adhesive by using a lower molecular weight hydrophilic polymer rather than by incorporation of additional polymers not contained within the wet matrix. When the dosage forms of the invention serve as transmucosal delivery systems, various carriers and additives may be incorporated as is well known in the art of transmucosal (e.g., buccal) drug delivery. Typical additives include permeation enhancers such as polyethylene glycol esters, long-chain fatty acid esters of diols and triols (e.g., glycerol monolaurate, propylene glycol monolaurate), lower alkanols, and the like.